Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-24 @ 10:37 PM
Study NCT ID:
NCT00349518
Status:
WITHDRAWN
Last Update Posted:
2016-02-17
First Post:
2006-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belgium', 'Czechia', 'Denmark', 'Finland', 'Germany', 'Greece', 'Ireland', 'Norway', 'Spain', 'Sweden', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2006-07-06', 'studyFirstSubmitQcDate': '2006-07-06', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of drug-related adverse events.'}], 'secondaryOutcomes': [{'measure': 'Chronic Phase CML: Cytogenetic and Hematologic Response'}, {'measure': 'Advanced Phase CML and Philadelphia positive ALL: Hematologic Response'}, {'measure': 'Time to and duration of Cytogenetic and Hematologic Response'}]}, 'conditionsModule': {'keywords': ['Chronic and Advanced Phase CML and', 'Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance'], 'conditions': ['Chronic Myeloid Leukemia', 'Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18 or older\n* CP or AD CML or Ph+ ALL\n* Intolerant of resistant to imatinib\n* ECOG PS 0-2 (CP CML)\n* ECOG PS 0-3 (AD CML and Ph+ ALL)\n* Adequate hepatic and renal function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding females\n* History of significant cardiac disease\n* History of significant bleeding disorder (not CML)'}, 'identificationModule': {'nctId': 'NCT00349518', 'briefTitle': 'Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib', 'orgStudyIdInfo': {'id': 'CA180-083'}, 'secondaryIdInfos': [{'id': 'EUDRACTnr: 2006-001279-39'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Dasatinib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Budapest', 'country': 'Hungary', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Orbassano (To)', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Local Instiution', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Local Institution', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Local Institution', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Glasgow', 'state': 'Central', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Newcastle', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}